Pharmaceutical & medical
the plant floor. These individuals can then apply principles of least privilege to users in different business areas – e.g. providing users with the minimum access they need to their work for the minimum time required. Legacy systems will not have admin
splitting features built into their design, and it is difficult to retrofit a solution. Fortunately, modern data acquisition systems like the SMARTDAC+ from Yokogawa make this process far easier as they can slot into a facility’s existing infrastructure, allowing older equipment to continue in operation without extensive changes or validation required.
The Devil is in The DeTails
At one time, auditors only required notes of significant changes, such as a colleague signing in to change an alarm. However, updated guidance seen in ‘21 CFR Part 11 Electronic Records; Electronic Signatures - Scope and Application’ now means colleagues must go through an audit trail to corroborate every change that has occurred during the production of a batch, no matter how inconsequential. This level of detail is undeniably good for robust
data collection. On the other hand, updates to guidance can significantly impact a plant’s competitiveness, increasing the time needed to check a product. It will also drag out the investigation process should an error be flagged. One way through this problem is by
adopting systems that request a reason for the change. Date and time stamps have long been part of audit trails, as have user accounts, but a clear way to explain colleagues’ actions has been lacking. A high- temperature alarm on a freezer, for example, may go off during production because someone left the door open too long. Traditional approaches to data acquisition would log this event in the audit trail but not offer any extra information – this makes the prospect of identifying and eliminating possible issues far more complex. Newer modular systems that offer a more
controlled summary of events, however, will help to speed up checks and encourage a more diligent approach to data integrity. Users that entered a dash or full stop in one of the entry boxes would soon be identified, encouraging them to provide fuller information the next time they are asked. These are just some of today’s challenges
and opportunities for data integrity in drug manufacturing. It could be argued that some of the measures discussed are unnecessary, especially given how compliance appears to be improving over time. That said, it would not be outlandish to suggest that guidance will soon become law. As such, it would be prudent for organisations to move towards more adaptable systems that promote best practices without significant disruption.
Yokogawa
www.yokogawa.com/uk/ Instrumentation Monthly January 2022 19
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